Intermittent Oral Tube in Alzheimer's Patients
- Conditions
- Alzheimer Disease
- Interventions
- Behavioral: Conventional CareDevice: Intermittent Oral-esophageal Tube FeedingDevice: Nasogastric tube
- Registration Number
- NCT06328829
- Lead Sponsor
- Copka Sonpashan
- Brief Summary
This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.
- Detailed Description
The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
- presence of no contraindication for enteral nutrition.
- with dysphagia verified by Imaging materials.
- with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
- Minimum Mental State Examination ranging from 10-26
- unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
- complicated with other intracranial lesions, such as stroke.
- abnormal structure of swallowing-related organ and tissue.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Care+Intermittent Oral-esophageal Tube Feeding Conventional Care During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support Conventional Care+Nasogastric tube Conventional Care During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The control group receives Nasogastric Tube Feeding for enteral nutrition support Conventional Care+Intermittent Oral-esophageal Tube Feeding Intermittent Oral-esophageal Tube Feeding During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The observation group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support Conventional Care+Nasogastric tube Nasogastric tube During the 15-day treatment, both groups of patients are hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The control group receives Nasogastric Tube Feeding for enteral nutrition support
- Primary Outcome Measures
Name Time Method Concentration of Total serum protein day 1 and day 15 Total serum protein was recorded through the blood routine test. (TP, g/L)
Concentration of Serum prealbumin day 1 and day 15 Serum prealbumin was recorded through the blood routine test.(PA, g/L)
Body Mass Index day 1 and day 15 Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2
Concentration of Serum albumin day 1 and day 15 Serum albumin was recorded through the blood routine test. (ALB, g/L)
Concentration of Hemoglobin day 1 and day 15 Hemoglobin was recorded through the blood routine test. (Hb, g/L)
- Secondary Outcome Measures
Name Time Method Pulmonary Infections day 1 and day 15 During the treatment, the occurrence of complications was recorded for both groups. These complications included but were not limited to: 1) Pulmonary Infections: Monitoring for the development of respiratory infections such as pneumonia or bronchitis.
Mini Nutritional Assessment day 1 and day 15 Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30. A higher score indicates the better nutritional status
Standardized Swallowing Assessment day 1 and day 15 The Standardized Swallowing Assessment Scale is a commonly used tool for evaluating swallowing function. It is widely applied in medical and rehabilitation fields to assess an individual's swallowing ability and the smooth passage of food/liquid through the esophagus. The scale ranges from 18 to 46, with lower scores indicating better swallowing function.